Documentation and Lessons Learned for the ONC LEAP Computable Consent Project.
23 Dec 2021 - Mohammad Jafari
The goal of the LEAP Consent Project was to provide a scalable architecture for capturing, managing, and enforcing patient consents based on the FHIR Consent resource. This post briefly discusses different aspects of scalability in consent management.
From the application perspective, a scalable architecture for consent management should accommodate the following dimensions of growth:
These aspects of scalability lead to a number of major requirements for a consent management solution and have been considered as major principles in the design of the LEAP Consent architecture:
From a technical standpoint, capturing, storing, and retrieving consents is rather similar to management of other types of documents and therefore not challenging per se. But consent enforcement is one of the bottlenecks where manual or proprietary solutions can impede scalability and interoperability.
To enable automatic and seamless integration of consent enforcement into different applications and workflows, it is imperative that consent rules are stated in machine-readable and interoperable form. Such rules can be processed by a decision engine to adjudicate whether the consent permits a specific given activity. This is one of the core features in ensuring a scalable consent architecture where large number of consents with complex rules can be efficiently enforced. Computable consents were one of the main focuses of the LEAP Consent project and one of its major contributions to the HL7 FHIR Consent specifications.